Performance of MicroTextured Dental Implants
This trial is active, not recruiting.
|Condition||partially edentulous jaw|
|Treatments||microtextured dental implant treatment, dental implant treatment|
|Sponsor||University of Alabama at Birmingham|
|Start date||May 2011|
|End date||June 2014|
|Trial size||60 participants|
|Trial identifier||NCT01821417, Z-11|
The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.
The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Change in millimeters of bone loss surrounding the implant device
time frame: Implant insertion, 12 months post-insertion
Millimeters of periodontal pocket depth surrounding the implant device
time frame: 2 months post- implant insertion
Changes in peri-implant gingivitis scores
time frame: implant insertion, 12 months post-insertion
Male or female participants at least 19 years old.
Inclusion Criteria: 1. Be a current registered University of Alabama at Birmingham (UAB)dental school patient 2. Existence of one or more missing teeth scheduled to be replaced with dental implants 3. Healthy enough to undergo proposed therapy without compromising existing health 4. Able to consent for their own inclusion 5. Able to read and understand the informed consent form 6. Demonstrated willingness to comply with protocol requirements and timeline Exclusion Criteria: 1. Any health condition that in the opinion of the investigators may adversely affect bone healing 2. Any medication that in the opinion of the investigators may adversely affect bone healing 3. Any indication of an inability to make autonomous decisions 4. Reported pregnancy at the time of enrollment -
|Official title||A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar|
|Principal investigator||Nicolaas C. Geurs, DDS.MS|
|Description||Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.|
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